ISO/IEC 17025:2017 – Internal Audit Guide

 

📘 ISO/IEC 17025:2017 – Internal Audit Guide

1. 🔎 Purpose of Internal Audit in ISO 17025

• Verify that the laboratory management system complies with ISO 17025:2017.

• Ensure technical competence of testing & calibration activities.

• Identify areas for improvement and risk mitigation.

• Provide confidence to customers, accreditation bodies, and regulators.

2. 📜 ISO 17025:2017 Clause on Internal Audit

• Clause 8.8 – Internal Audits requires that laboratories:

1. Conduct audits at planned intervals.

2. Cover all elements of the management system (technical & management).

3. Use auditors who are objective and independent of the area being audited.

4. Ensure audit results are reported to management.

5. Take corrective actions without undue delay.

3. 🎯 Objectives of ISO 17025 Internal Audit

• Confirm conformity to ISO 17025 requirements.

• Check compliance with laboratory policies, SOPs, and regulations.

• Assess effectiveness of the QMS.

• Identify risks and opportunities.

• Verify corrective actions from previous audits.

4. 🔄 Internal Audit Process (as per ISO 17025)

1. Planning

• Prepare an audit schedule (covering all processes within 12–24 months).

• Define audit scope, criteria, and methods.

• Select trained, independent auditors.

2. Preparation

• Review documents (Quality Manual, procedures, test methods, records).

• Create audit checklists aligned with ISO 17025 clauses.

3. Execution (Field Audit)

• Interview staff, observe activities, review records, and test reports.

• Verify technical competence (e.g., equipment calibration, method validation, traceability, uncertainty).

4. Reporting

• Document nonconformities (NCs), observations, and opportunities for improvement (OFIs).

• Classify findings by severity (major/minor NC).

5. Corrective Action & Follow-up

• Root cause analysis (RCA).

• Implement corrective action & preventive measures.

• Verify effectiveness during follow-up audit.

5. 📑 Audit Checklist (Sample Areas to Cover)

✔ Management system policies & objectives.

✔ Document control and record keeping.

✔ Personnel competence, training & authorization.

✔ Test/calibration methods & method validation.

✔ Equipment calibration, maintenance & traceability.

✔ Measurement uncertainty evaluation.

✔ Sampling procedures.

✔ Handling of test/calibration items.

✔ Reporting of results.

✔ Control of nonconforming work.

✔ Risk & opportunity management.

✔ Corrective actions from previous audits.

6. 📊 Benefits of Internal Audit under ISO 17025

• Ensures accreditation readiness.

• Builds customer confidence.

• Detects errors early → reduces risk of invalid results.

• Improves technical competence and consistency.

• Drives continuous improvement in the lab.

7. ✅ Best Practices

• Use risk-based planning (audit high-risk areas more frequently).

• Train auditors in ISO 17025 requirements + auditing techniques (ISO 19011).

• Ensure objectivity (auditors don’t audit their own work).

• Report findings in clear, evidence-based language.

• Involve management in closing NCs.

👉 Do you want me to prepare a ready-to-use ISO 17025 Internal Audit Checklist (Excel/PDF) or a training PPT for auditors?